Company Overview - Oculis is a global biopharma company listed on NASDAQ, focusing on ophthalmology and neuro-ophthalmology with late-stage registrational candidates [2] - The company has three candidates in Phase III trials and two main franchises [2] Product Pipeline - The first franchise includes OCS-01, which is the first noninvasive self-administered eye drop for diabetic macular edema (DME), with a readout planned for Q2 of this year [3] - The second candidate in this franchise is Licaminlimab, aimed at treating dry eye disease, with a readout expected in Q4 2026 [3] Neuro-Ophthalmology Franchise - The second franchise focuses on neuro-ophthalmology, featuring privosegtor, which is the first product to demonstrate effectiveness in neuroprotection [4] - Privosegtor has shown consistent results in preserving neurons across all endpoints, including functional, anatomical, and biological measures [4]

Summary of Oculis Conference Call Company Overview - **Company**: Oculis - **Industry**: Biopharmaceuticals, specifically in ophthalmology and neuro-ophthalmology - **Stock Exchange**: Nasdaq-listed - **Financial Position**: Strong balance sheet with no debt, cash runway until 2029 excluding a facility loan of CHF 100 million ($125 million) [2][3] Key Products and Pipeline Ocular Franchise - **OCS-01**: - First non-invasive self-administered eye drop for diabetic macular edema (DME) - Phase 3 readout planned for Q2 2023 - Targets a market of 1.8 million diagnosed patients in the US, with only half currently treated [2][5][6] - Demonstrated a 7.6 letters gain in best-corrected visual acuity (BCVA) at week 12 in trials, with 27% of patients gaining more than 15 letters [10] - Expected submission for approval in Q4 2023, with potential approval in 2027 [12] - **Licaminlimab**: - First precision medicine in ophthalmology for dry eye disease - Utilizes a biomarker to identify high responders, allowing for smaller and more efficient Phase 3 trials [12][13] - Expected top-line results in Q4 2026 [41] Neuro-Ophthalmology Franchise - **Privosegtor**: - First product in neuroprotection, targeting optic neuritis and NAION - Received Breakthrough Therapy Designation - Demonstrated preservation of retinal and ganglion cells in trials, with significant functional improvements [16][21] - Market potential of $7 billion for optic neuritis and NAION, with no current solutions available [18] - Phase 3 trials (Pioneer 1 and Pioneer 2) expected to start in 2026, with readouts planned for 2027 [23][35] Market Opportunity - **DME Market**: - Significant unmet medical need with a large patient pool, as DME is the leading cause of blindness in the working-age population in the US [34] - OCS-01 aims to address both early intervention and patients not responding to current treatments [7][9] - **Neuro-Ophthalmology Market**: - High potential due to the lack of existing treatments for conditions like optic neuritis and NAION, which are closely linked to multiple sclerosis (MS) [19][20] - Plans to expand treatment to all types of MS relapses, significantly increasing the addressable market [40] Strategic Focus - **Commercial Strategy**: - Focus on the US market for launch, with potential partnerships for ex-US markets [26] - Emphasis on innovative and differentiated product profiles to ensure successful commercial launches [26] - **Execution and Risk Management**: - Acknowledgment of execution risk as a primary concern, with a commitment to high-quality trial execution [31][32] - Confidence in the biological efficacy of products based on consistent preclinical and clinical data [39] Manufacturing and Partnerships - **Manufacturing Strategy**: - Oculis does not have in-house manufacturing capabilities; instead, it partners with established global manufacturers to maintain flexibility and quality [44] Conclusion - Oculis is positioned to make significant advancements in the ophthalmology and neuro-ophthalmology sectors with its innovative product pipeline, addressing critical unmet medical needs and leveraging a strong financial position for future growth [25]

Visionary Innovation Riad Sherif, M.D. Chief Executive Officer J.P. Morgan Healthcare Conference January 14, 2026 Safe Harbor Statements Cautionary note on forward-looking statements These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identi ...

– Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 – – Phase 2 CALLIPER Data Showed Vidofludimus Calcium Reduced 24-Week Confirmed Disability Worsening and Increased 24-Week Confirmed Disability Improvement Across Progressive Multiple Sclerosis and Its Subtypes, Reinforcing the Drug's Direct Neuroprotective Mechanism of Action – – Long-Term Open-Label Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in ...

Core Insights - Oculis Holding AG's neuroprotective candidate Privosegtor has received Breakthrough Therapy Designation from the FDA for the treatment of optic neuritis, highlighting its potential as a first-of-its-kind therapy in this area [1][7]. Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmology and ophthalmology, with a late-stage clinical pipeline that includes Privosegtor, OCS-01, and Licaminlimab [15]. Product Details - Privosegtor is a novel peptoid small molecule designed to penetrate both the blood-brain and retinal barriers, potentially addressing significant unmet medical needs in optic neuropathies, with a market opportunity estimated at $7 billion in the U.S. alone [2][5]. - The drug has shown substantial improvements in visual function, with an average gain of 18 letters in Low Contrast Visual Acuity (LCVA) compared to placebo in the Phase 2 ACUITY trial [4][7]. Clinical Trial Insights - The ACUITY trial demonstrated that Privosegtor not only improved visual function but also preserved anatomical structures of the retina and optic nerve, indicating its neuroprotective potential [3][4]. - The trial involved 36 patients with acute optic neuritis, showing that those treated with Privosegtor alongside IV methylprednisolone experienced significant visual improvements [12]. Regulatory and Market Implications - Following a successful meeting with the FDA, Oculis initiated the PIONEER program, which includes three pivotal trials aimed at supporting registration plans for Privosegtor in optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION) [5][6]. - The unmet medical needs in these conditions are significant, as there are currently no approved neuroprotective therapies available [10][11].

Summary of Immunic Therapeutics Conference Call Company Overview - **Company**: Immunic Therapeutics - **Focus**: Transforming the Multiple Sclerosis (MS) market with innovative treatments, particularly through the development of vidofludimus calcium [2][3] Key Points and Arguments Clinical Trials and Data - **Phase 3 Studies**: Two significant Phase 3 studies in relapsing MS are expected to yield data in the next year [2] - **CALLIPER Study**: Positive results from the Phase 2 study in progressive MS, showing a 34% reduction in disability worsening, which is the best result reported in any clinical trial to date [3][4] - **Statistical Significance**: Achieved statistical significance in disability score changes after 60 weeks, with a P value of 0.01 after 120 weeks [4] Mechanism of Action - **Neuroprotective Effect**: Vidofludimus calcium activates nuclear receptors, providing a direct neuroprotective effect, which is unique compared to other MS treatments that are primarily immunosuppressive [8][9] - **Hazard Ratio**: In the primary progressive MS population, the hazard ratio for improvement was reported at 2.8, indicating a threefold higher likelihood of benefit compared to placebo [4] Market Position and Competitive Landscape - **Oral Disease-Modifying Therapy Segment**: Vidofludimus calcium aims to compete in the oral therapy segment, which currently represents 40% of total prescriptions for MS [12] - **Differentiation**: The drug is expected to have a unique mechanistic advantage by addressing both relapse-associated worsening and progression independent of relapse activity [13][14] - **Safety Profile**: Vidofludimus calcium is anticipated to have a better safety and tolerability profile compared to existing oral therapies, which have serious safety concerns [14] Target Patient Segments - **Newly Diagnosed Patients**: Positioned as a first-choice option for newly diagnosed patients due to its safety and tolerability [15] - **Switching from Other Therapies**: Expected to be a logical switch for patients experiencing safety concerns with existing therapies, particularly those coming off anti-CD20 therapies [16][17] - **Market Opportunity**: Estimated market opportunity in the U.S. for patients switching from anti-CD20 therapies is between $500 million and $1 billion [17] Financial and Strategic Considerations - **Funding**: Recent capital raise of $65 million, with potential for an additional $65 million through cash warrants [21] - **Partnerships**: Ongoing discussions regarding potential partnerships to support clinical development and commercialization strategies [23][24] - **Commercial Strategy**: Aiming to build a commercial plan similar to successful small biotech companies, focusing on the unique value proposition of vidofludimus calcium [24] Other Programs - **IMU-856**: Demonstrated proof of concept in celiac disease, restoring the epithelial layer in the gut wall and showing functional improvements [25][26] - **Prioritization**: Current priority remains on executing the MS program while being prepared to advance other programs as funding allows [26] Additional Important Insights - **Market Growth**: The MS market is projected to grow from $23 billion to $30 billion, indicating ample space for multiple products [19] - **Regulatory Considerations**: Anticipation of regulatory focus on 24-week confirmed disability worsening as a pivotal endpoint for future studies [7] This summary encapsulates the critical insights from the conference call, highlighting Immunic Therapeutics' strategic direction, clinical advancements, and market positioning in the MS treatment landscape.

Summary of Oculis Holding (NasdaqGM:OCS) FY Conference Call Company Overview - Oculis is a biopharma company focused on neuro ophthalmology and ophthalmology, publicly listed on Nasdaq for two and a half years [4][2] - The company has three candidates in Phase III trials, with significant milestones expected from 2026 to 2028 [4][4] Key Assets and Mechanisms Privo Sector (Acute Optic Neuritis) - Privo Sector is a neuroprotective drug targeting acute optic neuritis, a condition often associated with multiple sclerosis (MS) [5][9] - The drug has shown promising results in preclinical and clinical trials, demonstrating neuroprotection and improved vision [16][16] - The market for acute optic neuritis is estimated to be between $6 billion to $7 billion, with no current competition [18][18] - The company plans to conduct two Phase III trials (PIONEER one and two) with a sample size of 180 to 200 patients each, expected to start recruitment within 12 months [31][31][54][54] Lecamilab (Dry Eye Disease) - Lecamilab is a TNF inhibitor targeting inflammation in dry eye disease, with a focus on a specific patient population identified by a biomarker [58][61] - The company aims to conduct a precision medicine approach, significantly reducing the patient population to 20% who are likely to respond positively to the treatment [59][61] - The ongoing PREDICT study is expected to read out results in the second half of next year [78][78] OCS O1 (Diabetic Macular Edema - DME) - OCS O1 is the first eye drop for retina in DME, currently in Phase III trials with readouts planned for Q2 next year [87][87] - The product aims to address early intervention in DME, targeting a larger patient population than currently treated [90][90] - The expected efficacy is comparable to existing treatments, with a goal of showing significant improvement in visual acuity [92][92] Financial Position - Oculis has a strong balance sheet with cash reserves expected to last until 2029, allowing the company to fund its six Phase III trials [98][98] Market Dynamics - The U.S. market for acute optic neuritis has approximately 60,000 to 70,000 patients annually, with pricing for orphan indications ranging from $100,000 to $400,000 [36][37] - The company has identified a small number of neuro-ophthalmologists (420) who will be able to prescribe its products, indicating a focused market entry strategy [38][38] Strategic Focus - Oculis plans to prioritize the Privo Sector while exploring partnerships for commercialization outside the U.S. [96][96] - The company aims to maintain a strong position before seeking partnerships, particularly after the readout of its DME trial [97][97] Conclusion - Oculis is positioned to make significant advancements in the treatment of acute optic neuritis, dry eye disease, and diabetic macular edema, with a robust pipeline and financial backing to support its clinical trials and market entry strategies [99][99]

Core Insights - Oculis Holding AG has advanced its candidate Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the FDA, marking a significant milestone for the company [2][3][7] - The PIONEER Program will include multiple global trials aimed at supporting registrations for Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [1][3][5] Company Overview - Oculis is a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic diseases with significant unmet medical needs [2][16] - The company is led by an experienced management team and supported by international healthcare investors [16] Product Development - Privosegtor is a novel peptoid small molecule candidate that has the potential to be the first neuroprotective therapy for AON and NAION [3][12] - The PIONEER program will consist of three pivotal trials: PIONEER-1 and PIONEER-2 for AON, and PIONEER-3 for NAION, with the first trial expected to start in Q4 2025 [4][5][8] Clinical Trials - PIONEER-1 and PIONEER-2 will evaluate Privosegtor in patients with AON, measuring low-contrast visual acuity at 3 months as the primary endpoint [4][5] - PIONEER-3 will evaluate Privosegtor after the acute onset of NAION, sharing core design elements with the other two trials [5] Market Potential - AON and NAION are rare neuro-ophthalmic diseases with high unmet medical needs for therapies that can provide neuroprotection and preserve vision [6][15] - The CEO of Oculis highlighted that the PIONEER program positions the company as a leader in ophthalmic neuroprotection drug development, targeting multi-billion-dollar markets [7][12] Financial Position - As of September 30, 2025, Oculis reported approximately $182 million in cash, cash equivalents, and short-term investments, with a cash runway expected into the second half of 2027 [9]

Core Viewpoint - Immunic, Inc. is actively participating in several scientific and investor conferences in October 2025 to present data on its clinical pipeline, particularly focusing on its orally administered therapies for chronic inflammatory and autoimmune diseases [1][2][3]. Conference Participation - Immunic's R&D team will present data on IMU-856 at the United European Gastroenterology Week (UEGW) in Berlin, Germany, from October 4-7, 2025, highlighting its positive effects on gut hormone levels in celiac disease patients [2]. - At the 17th International Congress of the International Society of Neuroimmunology (ISNI) in Chiba, Japan, from October 5-8, 2025, Immunic will present data on its lead asset, vidofludimus calcium (IMU-838), which exhibits signs of neuroprotection in preclinical models [2][3]. - Immunic's CEO and CFO will participate in the Roth's 4th Annual Healthcare Opportunities Conference in New York on October 9, 2025, discussing the next wave of innovation in underserved indications [2]. - A virtual fireside chat with Immunic's leadership will take place on October 23, 2025, as part of H.C. Wainwright's HCW @ Home event [2]. Clinical Development Programs - Vidofludimus calcium (IMU-838) is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. It has shown therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis [3]. - IMU-856 targets SIRT6 to restore intestinal barrier function and may be applicable in various gastrointestinal diseases, including celiac disease and inflammatory bowel disease [3]. - IMU-381, currently in preclinical testing, is a next-generation molecule aimed at addressing gastrointestinal disease needs [3].

Core Insights - Oculis Holding AG announced positive results from the Phase 2 ACUITY trial for Privosegtor (OCS-05) in treating acute optic neuritis, showing improved low contrast visual acuity and preservation of retinal ganglion cells [1][2][3] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a late-stage clinical pipeline that includes three core product candidates: OCS-01, Privosegtor (OCS-05), and Licaminlimab (OCS-02) [6] Trial Details - The ACUITY trial was a multicenter randomized placebo-controlled double-masked study, with results indicating a clinically meaningful improvement in vision by 18 letters at 3 months, alongside a favorable safety profile [2][3] - The trial results will be presented at the ECTRIMS 2025 Congress, highlighting the potential of Privosegtor in neuroprotection and its applicability in various neurological diseases [2] Drug Information - Privosegtor (OCS-05) is a novel peptoid small molecule candidate with neuroprotective properties, showing anatomical preservation of the retina and improvements in visual function in patients with acute optic neuritis [3][4] - The drug has received orphan drug designation from both the FDA and EMA for acute optic neuritis, indicating its potential for broader applications in neuro-ophthalmic and neurological conditions [3] Condition Overview - Acute optic neuritis is a rare condition affecting up to 8 in 100,000 people globally, often serving as the first sign of multiple sclerosis, primarily affecting adults aged 20 to 40, with a higher prevalence in women [5]